CompletedInterventionalNot ApplicableUpdated Oct 26, 2020
Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars | NCT01813786 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 28, 2020
Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars
ClinicalTrials.gov ID
NCT01813786
Lead Sponsor
Cynosure, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
9Actual
Last Update Posted
Oct 28, 2020Actual
Start Date
Dec 2012
Primary Completion Date
Dec 2013Actual
Completion Date
Dec 2013Actual
Brief Summary
Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.
Scars
755nm Alexandrite Laser with handpiece 2
755nm Alexandrite Laser with handpiece 1
755nm Alexandrite Laser with handpiece 3
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is a healthy male or female between 18 and 85 years old
Has unwanted scars not including atrophic scars and wishes to undergo laser treatments.
Is willing to consent to participate in the study.
Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
Has Fitzpatrick skin types I to IV.
Exclusion Criteria:
The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
The subject is hypersensitive to light exposure OR takes photo sensitized medication.
The subject has active or localized systemic infections.
The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
The subject has used Accutane within 6 months prior to enrollment.
The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
The subject has a history of keloids.
The subject has evidence of compromised wound healing.
The subject has a history of squamous cell carcinoma or melanoma.
The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
The subjects has an allergy to lidocaine and epinephrine.